Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
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Tue, 8 Dec
Wed, 9 Dec
Thu, 10 Dec
Fri, 11 Dec
0800 – 1700
Join us for an energizing, collaborative experience designed to bring Emerging Leaders together to solve real-world challenges facing the pharmaceutical industry. This is a two-day challenge and participants are expected to attend both days of the event. See Day 2 registration on Wednesday, 9 December.
1800 – 2100
Networking
Kicking off the 2026 ISPE Pharma 4.0™ and Biopharma Conference, we’re excited to invite you to a relaxed and energizing Tuesday evening Women in Pharma Walk Christmas market visit in beautiful Berlin! Whether you're reconnecting with colleagues or meeting new faces, this is a perfect way to start the week — with movement, conversation, and community. Meeting Point Brandenburg Gate we will gather here before starting our easy walk of approximately 3 km ending at the Christmas Market at Gendarmenmarkt. Any additional costs are the responsibility of the individual. This is available to ISPE Members only. Additional Details to follow for registered attendees.
0800 – 1700
Day 2 of the ISPE Hackathon builds on the momentum from Day 1 as teams finalize their projects before presenting to a panel of judges who will determine the winning solution.
0930 – 1230
Facility Tour
Join us for an exclusive tour of Der Simulierte Mensch (Si-M), a newly opened joint research center of TU Berlin and Charité – Universitätsmedizin Berlin. Located on Campus Seestraße in Berlin-Wedding, Si-M brings engineers and clinicians under one roof to simulate human physiology and pathophysiology in vitro and in silico — a research program built to reduce and replace animal testing while generating human-relevant data for oncology, immunology, and regenerative medicine. The tour offers a rare, behind-the-scenes look at the shared technology platforms that make this possible: Organs-on-a-Chip & Organoids — microfluidic multi-organ systems, vascularized and immune-competent organoid models, disease models, and CRISPR-based genetic modification 3D Bioprinting — fabrication of complex human tissue constructs Imaging — from fast live-cell microscopy to 2-photon spectral deep-tissue imaging and high-content screening Cytometry, Mass Spectrometry & Genomics — high-throughput single-cell and proteomic analysis integrated with automation XR-Lab (Living Lab) — 4D imaging and Extended Reality for biomedical visualization and surgical planning Theatron — the circular auditorium at the heart of the building, designed as an open interface between science, industry, and society Why this matters for Pharma 4.0: Si-M is a working example of a digitally integrated, human-based research infrastructure combining human cell and tissue models, organ-on-a-chip systems, and 3D bioprinting with integrated omics analysis and in silico modeling. For professionals working on digital transformation, advanced therapies, and next-generation preclinical development, the tour illustrates how connected, animal-free model systems and data infrastructure can shorten the path from biology to patient-relevant decisions. Following the walkthrough, participants will have the opportunity to speak directly with Si-M scientists and platform leads. Transportation and lunch are provided! To reserve your spot, be sure to add this to your registration for $100. Attendance is limited to 30.
1030 – 1300
Facility Tour
STE-1 facility tour:
During this tour, Bayer will present its latest investment in digitalized, robotized aseptic manufacturing for Phase 3 products and the launch of new modalities. The tour will begin with an introduction to the investment, followed by an explanation of material and personnel flows and a visit to the visitors’ corridor to view the line. As we cannot guarantee that the line will be running during the visit, the process will also be explained through a video. The presentation will highlight how Bayer plans to execute fill-finish operations in the future using cutting-edge technology.
Bayer Museum tour:
In the Historical Pharma Collection, attendees will get an overview of the history of Bayer Pharmaceuticals at the Berlin site "From the beginnings to the present".
Transportation and lunch are provided! To reserve your spot, be sure to add this to your registration for $75. Attendance is limited to 30. Photos not permitted.
1300 – 1700
Registration
1400 – 1700
Workshop
Vinzenz Zauner, Zauner Consulting
Michelle Vuolo, Tulip Interfaces
Paige Kane, PhD, CAI
Yvonne Duckworth, CRB
Pharma 4.0™ has moved past the phase where the industry needs convincing. Most organizations now accept the destination. What they lack is a route — and the honest conversation about what has to change in their control strategy, their organization, and their culture before any of it holds up to regulatory scrutiny.
The ISPE Pharma 4.0™ Community of Practice has spent the last three years building that route in guidance form. The ISPE Baseline® Guide Vol 8: Pharma 4.0™ established the operating model and the structural capabilities transformation requires. The ISPE Good Practice Guide: Pharma 4.0™ – Holistic Digital Enablement set out how to build and connect that digital capability across the value chain. The ISPE Good Practice Guide: Validation 4.0 addressed the question every quality organization eventually runs into: in a continuous, data-rich, highly integrated environment, how do we actually demonstrate and maintain control?
This three-hour workshop puts all three to work in one room.
The session is built around a single argument rather than a series of updates: know your risks, know your controls, and verify them continuously. Participants begin by locating their own organization on the maturity continuum and scoring themselves against the four Pharma 4.0™ enablers — Resources, Information Systems, Organization and Processes, and Culture — which surfaces where the real constraint sits. Experience suggests it is rarely the technology.
The session closes by mapping the CoP's active subcommittee work — and the conference program's own tracks and sub-tracks.
Intended audience: validation, quality, manufacturing, engineering, and IT/OT professionals with working familiarity with the process validation lifecycle and quality risk management fundamentals. No prior Pharma 4.0™ experience is assumed.
Participants will leave able to: place their organization on the maturity continuum and name their binding constraint; navigate the three-guide stack to the right answer for a given question; build a first-pass holistic control strategy for a process they own; and connect directly to the CoP work most relevant to it.
Validation exists to demonstrate control. Pharma 4.0™ makes it possible to demonstrate that control continuously rather than in snapshots — and continuous control is what ultimately gets a safe, effective product to a patient who is waiting for it.
1800 – 2100
Separate Registration Required
REGISTER HERE: Affiliate Evening Events - 2026 ISPE Pharma 4.0™ and Biopharma Conference
These curated evening formats, hosted by the ISPE D/A/CH Affiliate, are designed to strengthen community engagement, facilitate meaningful networking, and create additional value around the core conference program. The first evening will feature an informal Icebreaker Event, including a bar and aperitif hosted at a location close to the conference venue. This format is intentionally designed to bring together arriving participants, early attendees, and facility tour visitors in a relaxed setting, enabling them to connect, exchange ideas, and build relationships ahead of the official conference start.
REGISTER HERE: Affiliate Evening Events - 2026 ISPE Pharma 4.0™ and Biopharma Conference
These curated evening formats, hosted by the ISPE D/A/CH Affiliate, are designed to strengthen community engagement, facilitate meaningful networking, and create additional value around the core conference program. The first evening will feature an informal Icebreaker Event, including a bar and aperitif hosted at a location close to the conference venue. This format is intentionally designed to bring together arriving participants, early attendees, and facility tour visitors in a relaxed setting, enabling them to connect, exchange ideas, and build relationships ahead of the official conference start.
0700 – 1730
Registration
0800 – 0820
0820 – 0850
Europe—and Germany in particular—faces a persistent innovation challenge.
While the region excels in basic research, many scientific breakthroughs fail to reach the market because of a translation gap between publicly funded research and privately funded translational development. Recognizing this issue, governments have established targeted support programs in strategic sectors, including biotechnology.
However, these efforts are increasingly challenged by geopolitical developments, particularly the protectionist “most-favoured-nation” policies pursued by the United States. Despite these headwinds, biotechnology remains one of the few technology fields in which Europe has a realistic opportunity to compete globally with both the United States and China. The presentation will explore this potential and discuss practical measures to strengthen Europe’s biotechnology ecosystem and accelerate innovation transfer into commercial success.
0850 – 0920
General Session
Peter Neubauer, Technische Universität
Self-Driving Biolabs for Pharma 4.0™: Accelerating Bioprocess Development and Biocatalyst Optimization by Standardized PAT
Biopharma development remains slowed by sequential experimentation, complex biological variability, and the need to transfer robust knowledge into regulated production. The KIWI-biolab at TU Berlin demonstrates how self-driving laboratories can connect automated parallel bioreactors, standardized PAT implementation, FAIR workflow management, mechanistic and data-driven modelling, and closed-loop control into one learning infrastructure. A central element is the workflow management system that links experimental execution with computational decision-making and enables reproducible, interoperable high-throughput experimentation (1). As a PAT benchmark, automated Raman spectroscopy illustrates how powerful analytical technologies can be implemented in a modular, standardized and transferable manner, providing non-invasive, high-frequency information for real-time monitoring, state estimation and adaptive process control (2). Model predictive control and moving horizon estimation enable adaptive feeding strategies in parallel E. coli cultivations (3), while Bayesian model regression supports autonomous model identification and uncertainty quantification from robotic cultivation data (4). As an example of process optimisation, automated high-throughput screening combined with model-assisted analysis was applied to extracellular Fab production in E. coli, identifying process drivers and trade-offs under relevant bioprocess conditions (5). Together, these examples show how self-driving biolabs can accelerate bioprocess development, biocatalyst optimisation, quality assurance and transfer to biomanufacturing.
Contributors: Peter Neubauer, Christoph Lange, Simon Seidel, Fabian Schroeder-Kleeberg, Annina Kemmer, Mariano Nicolas Cruz Bournazou
Biopharma development remains slowed by sequential experimentation, complex biological variability, and the need to transfer robust knowledge into regulated production. The KIWI-biolab at TU Berlin demonstrates how self-driving laboratories can connect automated parallel bioreactors, standardized PAT implementation, FAIR workflow management, mechanistic and data-driven modelling, and closed-loop control into one learning infrastructure. A central element is the workflow management system that links experimental execution with computational decision-making and enables reproducible, interoperable high-throughput experimentation (1). As a PAT benchmark, automated Raman spectroscopy illustrates how powerful analytical technologies can be implemented in a modular, standardized and transferable manner, providing non-invasive, high-frequency information for real-time monitoring, state estimation and adaptive process control (2). Model predictive control and moving horizon estimation enable adaptive feeding strategies in parallel E. coli cultivations (3), while Bayesian model regression supports autonomous model identification and uncertainty quantification from robotic cultivation data (4). As an example of process optimisation, automated high-throughput screening combined with model-assisted analysis was applied to extracellular Fab production in E. coli, identifying process drivers and trade-offs under relevant bioprocess conditions (5). Together, these examples show how self-driving biolabs can accelerate bioprocess development, biocatalyst optimisation, quality assurance and transfer to biomanufacturing.
Contributors: Peter Neubauer, Christoph Lange, Simon Seidel, Fabian Schroeder-Kleeberg, Annina Kemmer, Mariano Nicolas Cruz Bournazou
0920 – 0930
General Session
Lineke Pelleboer, Bilthoven Biologicals
Markus Zeitz, PhD, Argenx
0930 – 1015
Networking
0930 – 1830
Networking
1015 – 1045
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Brice Dreamer, Eliquent Life Sciences
Michael Ruck, Eliquent Life Sciences
Few topics divide pharma like AI. One camp fears it will replace skilled people and erode compliance; the other expects it to fix everything overnight. The more useful (and more optimistic) reality sits in between: AI excels at the work people find hardest, sifting vast amounts of data consistently and without fatigue, while humans remain irreplaceable for judgment, creativity, and accountability. This session is deliberately broad, practical food for thought, not a deep technical dive. We map where AI genuinely helps in pharma manufacturing today and where it quietly fails; the human-factors trap of over-trusting a tool that is only "mostly right"; what is realistically coming next, illustrated by AI-assisted documentation and faster tech transfer; and the fast-moving regulatory horizon, including the EU AI Act and the draft EU GMP Annex 22, which writes "human-in-the-loop" into the rule and currently bars generative AI from critical GMP. We close with a simple decision framework: what to delegate to AI, what to keep human, and how to prove it is controlled, then open the floor. Attendees leave able to adopt AI responsibly without surrendering quality, control, or their signature.
1015 – 1045
Pharma 4.0™ Compliant by Design
Davide Fissi, PhD, Eli Lilly Italia SpA
The 2022 revision of EU GMP Annex 1 makes proactive contamination control a regulatory expectation through an inspection-ready, living Contamination Control Strategy (CCS). This abstract presents a practical framework to move sterile clean room management from reactive response to predictive control by deploying a validated digital twin. The approach combines 3D capture and BIM to verify layout and compliance against Annex 1 and ISO 14644, CFD to simulate airflow, pressure cascades and RABS/isolator integration before qualification, and IoT-enabled environmental monitoring to ingest particle, temperature, humidity and differential pressure data. A control-tower layer provides real-time trending, dashboards and excursion detection, while machine-learning models support anomaly detection, scenario-based virtual risk assessments and condition-based maintenance of HEPA filters and AHUs. Key applications include virtual pre-qualification reducing smoke-study iterations, predictive maintenance replacing time-based schedules, virtual change-control impact assessments prior to modifications, and immersive GMP training in a simulated environment. Overall, an integrated digital twin strengthens CCS justification, improves lifecycle risk management, and supports the operational goal of zero-contamination clean rooms.
1015 – 1045
Pharma 4.0™ Enabling Digital Foundations
Michelangelo Canzoneri, Merck KGaA Darmstadt, Germany
Christian Woelbeling, Körber Pharma Software GmbH
This presentation will explain the evolution of the ISPE Initiatives for Holistic Digital Transformations and Control Strategy design.
This includes the Holistic End to End strategic involvement of the pharmaceuticals organizations business units ranging along the ICH Q10 pharmaceutical lifecycle from process development, via clinical trials and IMP manufacturing up to tech transfer, scale up and commercial manufacturing. This involves in ISPE an interdisciplinary approach including for example the Advanced Pharmaceutical Quality / APQ Initiative from ISPE. Pharma 4.0 applies the digital toolbox of digitalization technologies like Augmented Reality, AI/ML, Speech Recognition etc. to enable organizations to change to a Pharma 4.0 based digitalized operating model.
1045 – 1115
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Tobias Merz, Bachem AG
This presentation explores how the organizational design of a major CAPEX program can enable effective integration of specialized technology expertise within a broader cross-functional project environment.
Drawing on lessons learned from a major CAPEX project at Bachem, this presentation examines how project structures, interfaces, and governance must be designed to support future ways of working by embedding a clear Industry 4.0 vision of digitalization, smart-factory development, and end-to-end integrated manufacturing that enables alignment, knowledge transfer, and decision-making across functions with different technical depth. The talk will explore three core themes: (1) how to set up a project organization that enables project success; (2) key lessons learned; and (3) why having a clear Industry 4.0 vision and end-to-end integration perspective from the outset is critical—not only for successful project delivery, but also for long-term operational excellence.
Drawing on lessons learned from a major CAPEX project at Bachem, this presentation examines how project structures, interfaces, and governance must be designed to support future ways of working by embedding a clear Industry 4.0 vision of digitalization, smart-factory development, and end-to-end integrated manufacturing that enables alignment, knowledge transfer, and decision-making across functions with different technical depth. The talk will explore three core themes: (1) how to set up a project organization that enables project success; (2) key lessons learned; and (3) why having a clear Industry 4.0 vision and end-to-end integration perspective from the outset is critical—not only for successful project delivery, but also for long-term operational excellence.
1045 – 1115
Pharma 4.0™ Enabling Digital Foundations
Domenico Guida, PiSA Farmacéutica
Ralf Wagner, Siemens
Emphasis will be placed on Live Performance Intelligence & Digital Escalation, the first initiative deployed within the program. This presentation will feature early results related to real-time performance monitoring, escalation logic, operational visibility, and immediate decision-making at shop floor level. In collaboration with Siemens, PiSA is also developing proofs of concept and proofs of value that combine standard digital manufacturing platforms with tailored developments in advanced analytics, machine learning, and large language models. These initiatives are designed to unlock the full potential of real-time data across nearly all macro-processes within an Oral Solid Dosage manufacturing site in Guadalajara, Mexico.
1045 – 1115
Pharma 4.0™ Compliant by Design
Wolfgang Winter, Agilent Technologies Deutschland GmbH
Nick Robbins, GSK
Rob Innes, Digital Technologies Group (DTG)
Smart factory systems are often considered relatively closed systems, as Pharma 4.0 accelerates operational technology systems to interconnect and integrate. While the "closed world" reduces the probability of conventional mass-attacks hurting a smart factory, attackers could compromise underlying machines or components to propagate to other parts of the system. This presentation puts cybersecurity risks for cyber-physical Pharma 4.0 systems into perspective. We reviewed industry best practices & foundations that minimize cyber-security risk exposure, maximize detection and mitigate & block intrusions, also in light of new & evolving legislation (CISA directives, European NIS-2, Cyber Resilience Act). Conclusion: Functional security can only be achieved with an integrated, holistic concept. Proven principles and established best practices from design & change controls to safety, risk management, verification & validation can be carried over to robust and continuous security but require a much faster cycle time.
1115 – 1145
Pharma 4.0™ Enabling Digital Foundations
Vanessa Akpore, Takeda
As organizations seek to advance their Pharma 4.0™ journey, many are establishing robust enterprise strategies and generating
increasing volumes of operational and financial data. Yet, CAPEX portfolios often continue to face challenges in decision-making, governance, and prioritization.
This session presents a practical framework to directly connect organizational strategy and decision-ready insights using Objectives and Key Results (OKRs) as the performance and governance mechanism. A structured OKR model, tailored for capital portfolios, will be presented including how to define outcome-based objectives, measurable key results, and a repeatable portfolio review cadence that links insights to execution.
Common pitfalls and pragmatic mitigation strategies will also be discussed through industry-based examples providing participants insights on how to move beyond simply reporting data and instead toward unlocking the full value of portfolio management in a Pharma 4.0™ environment.
increasing volumes of operational and financial data. Yet, CAPEX portfolios often continue to face challenges in decision-making, governance, and prioritization.
This session presents a practical framework to directly connect organizational strategy and decision-ready insights using Objectives and Key Results (OKRs) as the performance and governance mechanism. A structured OKR model, tailored for capital portfolios, will be presented including how to define outcome-based objectives, measurable key results, and a repeatable portfolio review cadence that links insights to execution.
Common pitfalls and pragmatic mitigation strategies will also be discussed through industry-based examples providing participants insights on how to move beyond simply reporting data and instead toward unlocking the full value of portfolio management in a Pharma 4.0™ environment.
1115 – 1145
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Kasper Olsen, Kuatro Group
Mikkel Wilmann, Novo Nordisk
Design Review is meant to confirm engineering intent, equipment scope, and safety-critical detail before a project advances. In practice, on large capital projects, that review is only as good as the data underneath it, and the data often remains locked inside legacy P&IDs, scanned drawings, and vendor documentation that has never been fully digitized. This session reframes Design Review as a data problem: what happens when the engineering data points a review depends on are incomplete, inconsistent, or simply unavailable in structured form.
Using a large-scale facility expansion at Novo Nordisk, where more than 45,000 components and 9 million data points across P&IDs, tag lists, and component specifications had to become reviewable and reusable, we deep-dive into the P&ID as the design control backbone and the failure modes that surface when tagging is inconsistent. We show how pairing engineers with an AI-assisted capture tool, rather than relying on manual transcription alone, turned design review from a paper-chasing exercise into a defensible, data-backed checkpoint, demonstrated live on stage.
Using a large-scale facility expansion at Novo Nordisk, where more than 45,000 components and 9 million data points across P&IDs, tag lists, and component specifications had to become reviewable and reusable, we deep-dive into the P&ID as the design control backbone and the failure modes that surface when tagging is inconsistent. We show how pairing engineers with an AI-assisted capture tool, rather than relying on manual transcription alone, turned design review from a paper-chasing exercise into a defensible, data-backed checkpoint, demonstrated live on stage.
1115 – 1145
Pharma 4.0™ Compliant by Design
Markus Zeitz, PhD, Argenx
Danilo Neri, PQE Group
The primary objective of this presentation and the upcoming GPG is to provide clear, actionable guidance on "how" to implement Pharma 4.0™ principles using real-world best practices and over 20 detailed use cases. The initiative seeks to shift the pharmaceutical paradigm from retrospective, paper-based compliance to a proactive, data-driven "Connected Quality" ecosystem that successfully integrates suppliers, manufacturing, quality control labs, and logistics.
This presentation defines the maturity path for Quality 4.0 across several critical pillars:
- Process Management as the Backbone: End-to-end process architecture is highlighted as the mandatory foundation for digitalization. Without structured process management, automation efforts risk creating a fragmented, ineffective patchwork of tools.
- Data-Centric Mapping: Organizations are urged to move away from isolated "Quality Islands" toward a connected landscape. Transitioning from process-centric to data-centric mapping allows management to explicitly track regulated data lifecycles, eliminate duplicate datasets, and understand systemic knowledge dependencies.
- Value Chain & Lifecycle Integration: By leveraging advanced technologies like AI and machine learning, digitalized quality reduces supply chain uncertainties (lowering excess inventory and lead times) and modernizes key
- Enablers and Culture: Aligning with ICH Q10, Knowledge Management (KM) and Quality Risk Management (QRM) are championed as twin enablers.
1145 – 1315
Networking
1315 – 1345
Pharma 4.0™ Compliant by Design
Jean-Pierre Doan, Merck KGaA
When a biopharma company and a regulatory authority share pharmaceutical data in a cloud environment, the governance challenge is not a configuration problem; it is a sovereignty problem. Contracts define intent. They do not enforce it.
The industry has spent decades governing data within the enterprise. But somewhere between the biopharma company and the regulatory authority, the pipeline turns into a PDF and a shared folder. That handoff is not just inefficient: it is a governance gap waiting to be named.
This presentation introduces a case study definition that maps the data governance requirements for a cloud collaboration between a biopharma company and an agency. It surfaces key challenges: Who technically controls access? How do you maintain an unforgeable record of who accessed what, when, and approved by whom, across two sovereign organizations? When an Agentic AI workflow routes data between parties, is that a technical event or a governance decision?
The case study definition applies learnings from a collaboration governance model in the mobility industry and ISPE Pharma 4.0 Holistic Digital Enablement Good Practice Guide to a cross-organizational environment for Industry and Agency collaboration.
1315 – 1345
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Peer Sander, INOSIM GmbH
Dennis Meister, Octapharma
As cost pressure and market competition continue to intensify, Pharma 4.0™ is becoming a strategic necessity for companies seeking to secure a competitive advantage. In the blood plasma industry in particular, increasing demand, strict regulatory requirements, and high product complexity require maximum transparency, robustness, and efficiency. These objectives can only be achieved through fully integrated digital solutions spanning the entire plant lifecycle. This presentation provides practical insights into how Octapharma leverages production simulation to generate measurable value from early design through optimization to live plant operations. Starting with sophisticated simulation models used in engineering projects, Octapharma and INOSIM have implemented a true Digital Twin application that supports day-to-day operations. This holistic Pharma 4.0™ approach is illustrated through real-world case studies.
1315 – 1345
Pharma 4.0™ Enabling Digital Foundations
Christophe Louis, UCB
Pharmaceutical organizations are accelerating AI adoption, yet many initiatives fail to translate into consistent impact. This session presents an alternative approach: using gamification as a mechanism to drive both adoption and measurable value from AI agents.
At UCB, we designed an immersive, simulation-based experience where participants actively build and apply AI agents to realistic pharma scenarios. Through simplified but representative challenges, such as operational trade-offs or submission-related decisions, participants explore how AI can support and transform decision-making in a regulated environment.
Gamification elements including competition, time pressure, and evolving scenarios create a setting where participants must make decisions, adapt their approach, and confront the consequences of their choices. This moves learning beyond conceptual understanding toward practical ownership and alignment. This session will share design principles, lessons learned, and how gamification can be used as a scalable lever to build shared understanding, realistic expectations, and sustained adoption of AI across the organization.
1345 – 1415
Pharma 4.0™ Compliant by Design
Paolo Braiuca, PhD, Seeq
Advanced data analytics has become a key enabler of robust continued process verification (CPV) and high equipment reliability. What often begins as an effort to enable real-time visibility into process and asset performance quickly matures into a strategic transformation, where analytics becomes the operational backbone for both quality and manufacturing. This presentation will explore how an interconnected analytics ecosystem spanning process data and quality platforms can drive the transition from basic monitoring to integrated CPV and reliable operations. Through examples of statistical process control, condition-based equipment monitoring, and advanced batch and CPV reporting, we will show how organizations can evolve from passive data review toward unified, insight-driven control of product quality and asset performance.
1345 – 1415
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Serkan Solmaz, UCB
Deviation management remains a highly resource intensive and quality critical process in biopharmaceutical manufacturing, often challenged by inconsistent documentation, variable investigation quality, prolonged cycle times, and limited reuse of historical knowledge.
This presentation introduces a GenAI-assisted deviation management strategy designed to augment, rather than replace, human decision-making across the deviation lifecycle. Core capabilities include real-time monitoring of investigation quality, AI-supported authoring of deviation records, and guided root cause analysis using structured methodologies such as 5 Whys and Fishbone.
These capabilities are being piloted within a human-centric and compliance-focused framework that ensures clear accountability, strong human oversight, and data integrity. The approach emphasizes positioning GenAI as a non-authoritative quality copilot, supporting users while maintaining full human ownership of decisions and outcomes. The session will also explore emerging, experimental approaches to enabling proactive deviation management through GenAI-driven pattern discovery across deviations and CAPAs.
This presentation introduces a GenAI-assisted deviation management strategy designed to augment, rather than replace, human decision-making across the deviation lifecycle. Core capabilities include real-time monitoring of investigation quality, AI-supported authoring of deviation records, and guided root cause analysis using structured methodologies such as 5 Whys and Fishbone.
These capabilities are being piloted within a human-centric and compliance-focused framework that ensures clear accountability, strong human oversight, and data integrity. The approach emphasizes positioning GenAI as a non-authoritative quality copilot, supporting users while maintaining full human ownership of decisions and outcomes. The session will also explore emerging, experimental approaches to enabling proactive deviation management through GenAI-driven pattern discovery across deviations and CAPAs.
1345 – 1415
Pharma 4.0™ Enabling Digital Foundations
Alexander Kunz, Merck KGaA Darmstadt, Germany
With the draft Annex 22, the pharmaceutical industry is about to receive its first dedicated regulatory guidance on the use of Artificial Intelligence and Machine Learning (AI/ML) in GxP regulated environments. This presentation introduces a practical AI use case developed under SMARTfacturing, an approach that applies data driven intelligence to level up operational excellence.
The draft annex defines expectations on the governance, validation, transparency and lifecycle management of AI/ML models in regulated environments. Industry gave its direct response to these requirements at the Annex 22 technical workshop on 30 June 2026, and the use case presented here reflects that response in practice. The result is an AI solution designed from the outset on the regulatory foundation now taking shape for AI in regulated manufacturing.
1415 – 1445
Pharma 4.0™ Compliant by Design
Igor Tomasevic, STADA
JELENA BATINIC, STADA
Andre Boyce, Arcadis
Scaling a modern data foundation (UNS) to execute Machine Data Connection (MDC) for Ongoing Process Verification (OPV), OEE and MES across multiple manufacturing sites/countries.
At the ISPE Europe annual conference in 2023, a modern data architecture deployment (UNS) was presented by the STADA group.
This presentation provides further insights into the opportunities that it has presented and some future capabilities that have been enabled for the business because of the foundational architecture.
Machine Data Connection for OPV is executed from the infrastructure on a publish basis to a group data hub, enabling visibility across the manufacturing network. Also made visible across the manufacturing network are the equipment OEE from multiple sites.
Machine Data Connection presents the improvement of data quality for the OPV System across the sites, leading to the OPV Enhancement, an increase in data integrity, and optimization of resources due to automated machine data as a source of critical process parameters for OPV. From the quality perspective, automated machine data gives real-time trending in the OPV System, elevated level of investigation quality for data analytics and enhanced compliance.
At the ISPE Europe annual conference in 2023, a modern data architecture deployment (UNS) was presented by the STADA group.
This presentation provides further insights into the opportunities that it has presented and some future capabilities that have been enabled for the business because of the foundational architecture.
Machine Data Connection for OPV is executed from the infrastructure on a publish basis to a group data hub, enabling visibility across the manufacturing network. Also made visible across the manufacturing network are the equipment OEE from multiple sites.
Machine Data Connection presents the improvement of data quality for the OPV System across the sites, leading to the OPV Enhancement, an increase in data integrity, and optimization of resources due to automated machine data as a source of critical process parameters for OPV. From the quality perspective, automated machine data gives real-time trending in the OPV System, elevated level of investigation quality for data analytics and enhanced compliance.
1415 – 1445
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Andrea Kurz, F. Hoffmann-La Roche Ltd in Basel
Dominik Wendel, F. Hoffmann-La Roche AG
Frank Seibel, Roche
This presentation explores how Roche takes a holistic view of evolving regulatory expectations - specifically navigating the modern landscapes of the EU GMP Chapter 4 on Documentation, the Annex 11 (Computerized Systems) and the upcoming Annex 22 (Artificial Intelligence). Furthermore, the presentation will show how data governance is a core business enabler that bridges the evolving compliance requirements with the rapidly evolving digital/AI innovation on the example of a Biomanufacturing facility. The presentation will explore how to create a scalable and sustainable foundation for continuous network adoption.
1415 – 1445
Pharma 4.0™ Enabling Digital Foundations
Hubertus Rehbaum, Dr. Rehbaum Technology Consulting GmbH
Meike Roemer, Bayer AG
Although Process Analytical Technology and Artificial Intelligence both rely on models implemented within computerized systems, there is often confusion about their fundamental differences particularly in validation and lifecycle management. PAT combines analytical methods with multivariate models, such as partial least squares regression, to correlate sensor data with validated analytical reference methods. Its outputs are deterministic, ensuring reproducibility for identical inputs. PAT operates within a well-established ICH regulatory framework, with method validation approaches aligned with established GMP quality control practices. These models are transparent, interpretable, and governed by clearly defined acceptance criteria. In contrast, AI leverages heterogeneous data sources, such as websites, data aggregators, and sensors, through advanced AI/ML systems and large language models. AI models may yield varying results as they evolve with new data. Emerging regulatory guidance, including FDA and EU GMP Annex 22 drafts, introduces risk-based credibility concepts such as Context of Use, transparency, data provenance, and bias mitigation within the broader framework of computerized system validation. As a result, AI lifecycle management emphasizes continuous post-deployment monitoring and predefined change control strategies rather than static recalibration. Used together PAT and AI offer strong complementary potential and, when appropriately integrated, can support reliable, data-driven decision-making in smart manufacturing environments.
1445 – 1530
Networking
1530 – 1600
The presentation will describe the Merck journey for implementation of end to end continuous manufacturing of Biologics from ideation over proof of concept until full implementation for clinical manufacturing. It will further describe the benefits and impact this change has delivered: better quality of difficult to produce complex molecule formats, decreased capital expenditure for implementation of new plants with decreased lead time, speed to clinics, higher productivity and thereby decreased Cost of goods. Merck is implementing this new technology across the whole Biologics pipeline and some tangible examples including feedback from Competent Authorities will be shown.
1600 – 1700
General Session
Michelangelo Canzoneri, Merck KGaA Darmstadt, Germany
Lineke Pelleboer, Bilthoven Biologicals
Adrian Widmer, Roche
Markus Zeitz, PhD, Argenx
Kim Hewson, GSK
This panel discussion addresses the critical move away from the "data tax" that currently costs the pharmaceutical industry significant resources through fragmented, non-machine-readable silos. The discussion will focus on a unified commitment to open standards and open-source technologies - specifically Asset Administration Shell (AAS) and Module Type Package (MTP) - to overcome vendor lock-in and enable universal interoperability.
Michelangelo Canzoneri
Global Head of Group Smart Manufacturing
Merck KGaA Darmstadt, Germany
Merck KGaA Darmstadt, Germany
Lineke Pelleboer
Senior Business Developer
Bilthoven Biologicals
Bilthoven Biologicals
Adrian Widmer
Global Head of Digital, AI & Operational Excellence (interim)
Roche
Roche
Markus Zeitz, PhD
DT Lead TechOps & Quality
Argenx
Argenx
Kim Hewson
Engineering Automation Solutions Director
GSK
GSK
1700 – 1830
Networking
1900 – 2300
Separate Registration Required
Offsite - Lindenbräu am Potsdamer Platz
REGISTER HERE: Affiliate Evening Events - 2026 ISPE Pharma 4.0™ and Biopharma Conference
These curated evening formats, hosted by the ISPE D/A/CH Affiliate, are designed to strengthen community engagement, facilitate meaningful networking, and create additional value around the core conference program. The second evening will host a larger, more structured Networking Dinner on Thursday, bringing together conference attendees, speakers, sponsors, and community members. This dinner will serve as a key social anchor, fostering deeper connections across companies, roles, and geographies in a more dedicated and engaging environment.
Offsite - Lindenbräu am Potsdamer Platz
REGISTER HERE: Affiliate Evening Events - 2026 ISPE Pharma 4.0™ and Biopharma Conference
These curated evening formats, hosted by the ISPE D/A/CH Affiliate, are designed to strengthen community engagement, facilitate meaningful networking, and create additional value around the core conference program. The second evening will host a larger, more structured Networking Dinner on Thursday, bringing together conference attendees, speakers, sponsors, and community members. This dinner will serve as a key social anchor, fostering deeper connections across companies, roles, and geographies in a more dedicated and engaging environment.
0700 – 1700
Registration
0800 – 0810
0810 – 0820
0820 – 0850
General Session
Christopher Grail, Bayer AG
Over the past few years, Bayer has fundamentally transformed its operating model, moving away from traditional hierarchies towards empowered teams with clear ownership. The organization is now built around Capability Clusters that are closely connected to products and, ultimately, to patient needs.
This keynote will explore how this shift is actively driving the adoption of Pharma 4.0 and acting as a key enabler for innovation. Particularly in the field of ATMPs, Bayer leverages its new organizational set-up together with an ecosystem of arm’s-lengths companies to push the boundaries of unmet medical needs for patients – utilizing the potential of Pharma 4.0 technologies.
Exploring use cases from Bayer’s two ISPE FOYA-winning facilities, SOLIDA-1 and the Cell Therapy Facility CCTC, we will demonstrate how interdisciplinary teams have successfully implemented advanced robotics applications, transferred the first product into the new SOLIDA-1 facility, as well as the introduction of new automation capabilities to enable efficient manufacturing in the CCTC facility.
Bringing Pharma 4.0 to life and generating sustainable value requires far more than technology alone: it needs skilled, capable and engaged as well as fully empowered people who want to make a difference.
0850 – 0920
General Session
Adrian Widmer, Roche
Jan Wokittel, Hoffmann-La Roche
In this keynote, "Beyond the Hype: How Roche Turns Smart Manufacturing Strategy into Reality," we move past the buzzwords of AI and Pharma 4.0™ to examine the foundational work required for successful digital transformation. By detailing Roche’s global smart manufacturing framework—including unified data architectures and edge-to-cloud connectivity—we share an honest look at three practical use cases and the realities of scaling across a complex, global network. This session addresses the infrastructure challenges that vendors rarely discuss, offering a candid perspective on lessons learned, the future of autonomous manufacturing, and a call for industry-wide transparency to better serve patients.
0920 – 0930
General Session
Lineke Pelleboer, Bilthoven Biologicals
Markus Zeitz, PhD, Argenx
0930 – 1330
Networking
0930 – 1015
Networking
1015 – 1045
Pharma 4.0™ Enabling Digital Foundations
Jean-Luc Gerling, Merck KGaA
Jeremy Ruiz, Lonza AG
Thomas Makait, MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance
Modular manufacturing is becoming a key enabler for Pharma 4.0™ but implementing "plug-and-produce" in regulated environments requires more than technical connectivity. It depends on standardized module descriptions, interoperable orchestration, and appropriate computerized systems validation including equipment qualification approach. Without this approach, promises of modular, flexible plants cannot be delivered in GxP-environments. While a modular plant may be technically flexible, lagging computerized systems validation, including equipment qualification activities, eliminate most of the efficiency gains the MTP-Standard entails.
This presentation will focus the regulated company's perspective on how to reduce regulated companies initial and recurring on-site computerized systems validation including equipment qualification effort by up to 60 %. The presenters will share how their input was derived from real implementation projects to the ongoing writing effort by the ISPE Pharma 4.0™ Plug & Produce Working Group and the Global ISPE GAMP Special Interest Group MTP in Pharma while developing a practical guidance on the implementation of Module Type Package (MTP) standard-based automated manufacturing systems in GxP-regulated environments.
1015 – 1045
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Christian Lavarreda, Syntegon
Amit Kumar, PhD, Wood Group
Biologic drug product manufacturing success increasingly hinges on modality-tuned formulation and fill-finish executed within a Pharma 4.0™ framework. This session maps modality requirements—mAbs/multispecifics, ADCs/bioconjugates, mRNA/LNPs and oligonucleotides, and viral vector/cell therapies—to concrete formulation and aseptic processing strategies. For formulation, we detail closed, plug-and-produce solutions with recipe driven automation, HPAPI containment for ADCs, and PAT for microfluidic LNP formation—each augmented by AI models for endpoint prediction and real time release readiness. Digital twins accelerate recipe and lyo cycle design, while MES/eBR and CPV analytics connect tech transfer to routine monitoring. For fill finish, we cover particle-free transport systems, robotics and isolators, closed transfers, RTU components, lyophilization capacity strategies, automated visual inspection/serialization, and CCI risk reduction. Attendees receive a modality aligned playbook to prioritize digital, modular, and automation investments that shorten commissioning, strengthen compliance, and enable resilient biologic drug product manufacturing operations.
1015 – 1045
Pharma 4.0™ Compliant by Design
Abhinav Arora, ReveonAI Lifesciences
Devendra Sharma, ReveonAI Lifesciences Solutions Pvt. Ltd.
AI-driven QMS simplification can help pharmaceutical organizations reduce document complexity while maintaining GMP compliance and operational clarity. This presentation introduces an end-to-end framework covering document-level gap assessment, portfolio rationalization, and simplified document rewriting.
The approach uses AI agents to assess existing QMS documents for structure, scope, governance alignment, quality benchmarks, duplication, and simplification opportunities. At the portfolio level, documents are mapped for cross-references and parent-child relationships to support data-driven recommendations on whether each document should be retained, merged, split, or retired. Once the approved document list is finalized, AI-assisted writing agents generate simplified, compliant drafts using validated inputs, governance checklists, and human-in-the-loop QA review.
The session will highlight how this approach can reduce training burden, improve consistency, enhance document usability for operators, and create clear rationale logs and traceability for audit readiness.
The approach uses AI agents to assess existing QMS documents for structure, scope, governance alignment, quality benchmarks, duplication, and simplification opportunities. At the portfolio level, documents are mapped for cross-references and parent-child relationships to support data-driven recommendations on whether each document should be retained, merged, split, or retired. Once the approved document list is finalized, AI-assisted writing agents generate simplified, compliant drafts using validated inputs, governance checklists, and human-in-the-loop QA review.
The session will highlight how this approach can reduce training burden, improve consistency, enhance document usability for operators, and create clear rationale logs and traceability for audit readiness.
1045 – 1115
Applying Artificial Intelligence to Deviation Investigations
Deviation investigations in pharmaceutical manufacturing are often time-consuming, knowledge-intensive, and heavily dependent on the experience of individual investigators.
The presentation introduces the concept and implementation of an “Investigation Agent” — an AI-supported Workflow designed to support deviation investigations by consolidating relevant knowledge, retrieving contextual GMP information, analyzing historical deviations, and proposing potential hypotheses and investigation pathways and draft a Report.
The presentation will demonstrate how the Problem Statement of time-consuming deviation investigations can be addressed with an agentic workflow and re-use existing knowledge across different manufacturing sites.
Propositional logical concept for defendable investigations will be presented.
1045 – 1115
Pharma 4.0™ Enabling Digital Foundations
Hernan Vilas, HVILAS Consulting GmbH
Thomas Halfmann, Eschbach GmbH
Manufacturing Execution Systems (MES) are at a critical point. In increasingly complex pharmaceutical manufacturing environments, MES is evolving from a transactional system of record into a central orchestrator of digital manufacturing ecosystems. This presentation, on behalf of the ISPE MES Sub-Committee, explores how MES will remain relevant and even gain strategic importance in the era of AI and advanced digitalization.
We will examine the convergence of MES with modern IT/OT architectures, including Unified Namespace concepts, modular and composable system design, and the integration of real-time data platforms. Furthermore, we will explore how AI will reshape manufacturing operations, from predictive quality and adaptive scheduling to AI enabled decision support, while reinforcing the foundational role of MES as the system ensuring contextual integrity, compliance, and execution control in regulated environments.
We will examine the convergence of MES with modern IT/OT architectures, including Unified Namespace concepts, modular and composable system design, and the integration of real-time data platforms. Furthermore, we will explore how AI will reshape manufacturing operations, from predictive quality and adaptive scheduling to AI enabled decision support, while reinforcing the foundational role of MES as the system ensuring contextual integrity, compliance, and execution control in regulated environments.
1045 – 1115
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Erick Mattos, Johnson & Johnson
Jiasheng Yang, Bausch+Ströbel SE + Co. KG
Determining optimal filling parameters for parenteral drug products presents a significant challenge due to the unique properties of each product, target dosing volumes, and the wide range of filling line configurations across different manufacturing sites. Establishing appropriate parameters for new processes or adapting existing ones often requires extensive trial-and-error, which can disrupt production schedules and consume substantial resources.
Computational Fluid Dynamics (CFD) offers a promising solution by enabling the prediction and validation of filling parameters through detailed simulations. This approach allows for efficient exploration of the design space with minimal experimental effort, accelerating process development at any stage. When combined with validated CFD data across various configurations, artificial intelligence (AI) can further enhance this process by developing predictive models that enable rapid identification of optimal parameters.
This presentation aims to provide an overview of the process development for parenteral drug products, emphasizing the creation of digital twins of filling operations. It will explore how CFD and AI-driven modeling can be integrated to streamline the development process and improve control over fill accuracy, ultimately leading to more robust and efficient manufacturing processes.
1115 – 1145
Pharma 4.0™ Compliant by Design
Pavan Pasupulati, Caliber Technologies
AI-powered policy-first platform that transforms SOPs into intelligent, context-aware workflows and dynamic electronic logs, enabling compliant, adaptive, and predictive Pharma 4.0™ manufacturing operations with real-time operational intelligence. The session will demonstrate how standard operating procedures (SOPs) can be digitally orchestrated into dynamic electronic logs and guided workflows that enable real-time compliance, operational consistency, and predictive manufacturing intelligence. By integrating AI-driven decision support with electronic execution frameworks, organizations can reduce manual effort, improve data integrity, accelerate deviations management, and establish scalable digital manufacturing foundations. The presentation will further address implementation approaches designed to minimize disruption to existing validated systems while enabling a phased transition toward future-ready Pharma 4.0™ operations.
1115 – 1145
Pharma 4.0™ Enabling Digital Foundations
Carsten Pedersen, NNIT
Establishing digital recipes in MES is the core of digital transformation in manufacturing. Current effort and investments are substantial, and many end users have programs that run for years. However, there is significant variation in execution of recipe implementation and maintenance across industry. Implementations are not delivered consistently which is usually due to specific properties of digital recipes. This is documented with feedback collected across more than 15 end user organizations. The variation in deployment and the rigidness of maintenance for recipes reduces trust in execution of digitalization programs and is a significant barrier for digitalization in general. It is critical the industry work to improve recipe lifecycle management.
1115 – 1145
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Francois Faul, SKAN AG
Tobias Ruof, Realworld One
Aseptic manufacturing relies on highly skilled operators whose actions directly influence product quality, process reliability, and patient safety. However, maintaining consistent operator performance across shifts, sites, complex modalities, and experience levels remains a significant challenge. Deviation data across the industry consistently points to one root cause: inconsistent operator execution. This session shows how inconsistent operator execution is addressed. SKAN brings proprietary insight into exactly how and where operators fail inside an isolator. Realworld One brings the Virtual Reality (VR)-enabled platform to engineer execution consistency and measure it against plant KPIs. Case data shows how simulation-based capability building directly links to lower deviation rates and reduced unplanned downtime. In aseptic manufacturing, operator execution consistency has become a measurable operational KPI with a defensible business case.
1145 – 1300
Networking
1300 – 1330
Pharma 4.0™ Enabling Digital Foundations
Enzo Birindelli, Italia Automazione Srl
Frank Maurer, Boehringer Ingelheim Pharma GmbH & Co KG
For two decades, pharmaceutical manufacturers have invested heavily to make IT and OT systems talk to each other. Integration layers, middleware, and custom interfaces each bridge worlds that were never designed to be one. Yet integration only makes these worlds coexist; it does not unify them. Software Defined Automation (SDA) offers a different path. Co-presented by the CEO of an independent automation consultancy and an owner-company automation leader, this session examines what convergence, not integration, means. We examine how convergence relates to the regulatory expectations of GxP manufacturing, address vendor lock-in candidly, and explore the organizational courage convergence demands. AI is the urgency accelerator: real-time release testing, continuous process verification, and bioreactor monitoring all assume a converged data foundation that integration layers struggle to deliver. Attendees leave able to distinguish integration from convergence, to weigh the business case, and to see the regulatory questions and cultural change still to be worked through. Software Defined Automation is the technical shift that makes convergence real: control abstracted from hardware, versioned, and deployed as software. The choice every pharma manufacturer now faces is whether to keep bridging IT and OT, or to converge them, and this session frames that decision.
1300 – 1330
Pharma 4.0™ Compliant by Design
Yanet Flor, GMP Check
What Inspectors Really Expect from Pharma 4.0™ Systems Powered by ISPE Women In Pharma
This session explores how regulatory expectations are evolving as pharmaceutical operations become increasingly digitalized through MES, electronic batch records, cloud-based systems, advanced analytics and AI-supported quality processes.
While Pharma 4.0™ creates major opportunities for efficiency and control, it also introduces new inspection challenges related to data integrity, governance, traceability and the reliability of digital evidence.
Drawing from practical GMP audit and inspection experience, this presentation will examine what generates trust in highly digital environments, common findings related to audit trails, user access, hybrid systems, and AI-assisted decisions, and how companies can strengthen inspection readiness through clear digital governance.
The session will also briefly address the FDA PreCheck Pilot Program as an example of how regulators may increasingly move toward more predictive and data-enabled oversight models. The presentation supports this topic by translating regulatory trends in Pharma 4.0™ into practical GMP expectations and actionable strategies for organizations implementing smart technologies and preparing for inspections. ...
This session explores how regulatory expectations are evolving as pharmaceutical operations become increasingly digitalized through MES, electronic batch records, cloud-based systems, advanced analytics and AI-supported quality processes.
While Pharma 4.0™ creates major opportunities for efficiency and control, it also introduces new inspection challenges related to data integrity, governance, traceability and the reliability of digital evidence.
Drawing from practical GMP audit and inspection experience, this presentation will examine what generates trust in highly digital environments, common findings related to audit trails, user access, hybrid systems, and AI-assisted decisions, and how companies can strengthen inspection readiness through clear digital governance.
The session will also briefly address the FDA PreCheck Pilot Program as an example of how regulators may increasingly move toward more predictive and data-enabled oversight models. The presentation supports this topic by translating regulatory trends in Pharma 4.0™ into practical GMP expectations and actionable strategies for organizations implementing smart technologies and preparing for inspections. ...
1300 – 1330
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Nandita Vishwanathan, Merck KgaA
End-to-end robotization is a strategic pathway to accelerate biotechnology process development. Automated, integrated robotic platforms can shorten development timelines, improve data quality, and enable scalable, parallel workflows across diverse modalities. Our technical vision centers on deploying modular robotic platforms that support miniaturization and high-throughput operations.
Emphasis is placed on end-to-end data flows, from cell line development through analytical readouts, with parallelization and workflow standardization at the core. Real world use case of fully automated downstream development will be presented. This approach enables faster experimentation, more reproducible results, and better utilization of laboratory resources while upholding Quality by Design principles and rigorous data governance.
By unifying analytical methods and standardizing workflows, the initiative seeks to transform how early prototypes become robust, clinically relevant candidates. The challenges in our journey include vendor management, the need for initial capital investment, programming complexity, and changes to lab culture and safety practices. These are being addressed through careful change management, comprehensive training, and integration with the existing digital architecture. Robust data management and platform interoperability are identified as critical enablers of long-term success.
1330 – 1400
Pharma 4.0™ Enabling Digital Foundations
Philipp Kläsle, F.Hoffmann-La Roche AG
Mugunthan Maheswaran, F. Hoffmann La Roche Ltd
Damian von Blarer, F. Hoffmann La Roche Ltd
Cutover with no roll-back option is a high-stakes maneuver designed to minimize downtime production loss. When synchronized with simultaneous ERP and Warehouse Management System (WMS) replacements, the complexity doesn't just triple; it grows exponentially. This presentation explores the reality of replacing a highly integrated legacy MES - the beating heart of Pharma 4.0 - under such volatile conditions. We examine the critical hurdles of project governance and the relevance of defining meaningful KPIs in such a multi-project environment while navigating constant scope creep, the alignment of new global processes with existing local processes and the "moving target" of integration testing with incomplete master data.
1330 – 1400
Pharma 4.0™ Compliant by Design
Oliver Herrmann, QFINITY Quality Management
AI changes how computerized systems behave. Execution shifts from operation to supervision, deterministic logic gives way to probabilistic output, and the demands on Quality Assurance rise with it. A model that performs well in general can still decide incorrectly inside a defined business process, because AI produces plausibility and the gap between a plausible output and a correct decision closes by design, never by trusting the model. Human oversight is where this becomes concrete: treated as a check at the end of the line, it controls nothing; designed into the architecture, it holds. Drawing on the GAMP AI Guide, this session introduces Progressive QA and shows how quality emerges from the interaction of processes, data, software, and decision structures, why QA has to become a driver of system architecture rather than a downstream control, and how oversight built in from the start creates AI-enabled GxP environments that scale and still hold. Capability is not reliability. The work of QA is to make the difference visible before the system does.
1330 – 1400
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Tishwant Kanwarjit, Autolus
Alfred Penfold, PM Group
The proposal is to cover the many challenges with ATMPs and how some of these challenges are being addressed with a glimpse into the future with reference to Pharma 4.0™. ATMPs were introduced approximately 20 years ago. 10 years ago, it was all about the science and making it work for the patient with no big pharma companies investing in ATMPs. That has changed. Today it is more about access to patients with plenty of big Pharma companies investing in ATMPs. ATMPs are known to have the highest quality gains and are truly transformational when compared to other modalities. It may take another 10 to 15 years to see the type of progress we have seen with other modalities such as Therapeutic Proteins. Autolus in Stevenage in the UK will explain their journey with CAR-T therapies and how they have tried to remain ahead of the curve.
1400 – 1430
Pharma 4.0™ Enabling Digital Foundations
Aurelie Demont, Mettler Toledo
Moira Schuler, Wacker Biotech
Most biomanufacturing facilities today are not greenfield plants but complex brownfield environments, having evolved over years or even decades. Within these facilities, a significant amount of valuable process data is continuously generated, particularly from measurement technologies such as weighing systems. Much of this data remains underutilized, confined to the instrument level/local applications, frequently retained only for compliance purposes rather than operational insight.
Unlocking and integrating this measurement data represents a critical step toward digital transformation. Once made accessible, it enables a shift from reactive to predictive manufacturing. By upgrading key components, e.g. as instrument terminals, while maintaining established automation systems, it is possible to integrate data into a centralized systems. This approach preserves prior investments while enabling advanced analytics capabilities.
This talk illustrates these principles through the example of a biologics plant originally built in the 1980s that recently underwent a brownfield upgrade. A new automated microbial fermentation line, including buffer preparation and downstream processing, was successfully integrated with the existing facility. The project followed a structured approach: assessing current assets, identifying critical elements, defining the desired end state, and executing on a proven way to implementation, demonstrating a practical pathway to modern digital manufacturing.
Unlocking and integrating this measurement data represents a critical step toward digital transformation. Once made accessible, it enables a shift from reactive to predictive manufacturing. By upgrading key components, e.g. as instrument terminals, while maintaining established automation systems, it is possible to integrate data into a centralized systems. This approach preserves prior investments while enabling advanced analytics capabilities.
This talk illustrates these principles through the example of a biologics plant originally built in the 1980s that recently underwent a brownfield upgrade. A new automated microbial fermentation line, including buffer preparation and downstream processing, was successfully integrated with the existing facility. The project followed a structured approach: assessing current assets, identifying critical elements, defining the desired end state, and executing on a proven way to implementation, demonstrating a practical pathway to modern digital manufacturing.
1400 – 1430
Pharma 4.0™ in Action:Biopharma Manufacturing Transformation
Faryal Khan, CRB
CAR-T therapies carry extraordinary promise. Yet manufacturing remains a major barrier in scaling them. Producing a single start per day (SpD) can require more than a dozen operators and that count does not include environmental monitoring, analytics, warehousing, and support functions. This labor intensity drives high cost and large facility footprints, making it harder to get these therapies to patients.
We will share lessons from two autologous CAR-T facilities that took different approaches. One relied entirely on manual operations and experienced high FTE counts, QC bottlenecks, and an unsustainable cost per dose. The other leveraged selective automation, robotics, and smart manufacturing principles to reduce labor demands while maintaining product integrity.
This session challenges the idea that CGT facilities must remain so labor intensive. By examining how automation, robotics, and facility design can complement human expertise, this session explores practical ways to make CAR-T manufacturing more scalable and sustainable.
We will share lessons from two autologous CAR-T facilities that took different approaches. One relied entirely on manual operations and experienced high FTE counts, QC bottlenecks, and an unsustainable cost per dose. The other leveraged selective automation, robotics, and smart manufacturing principles to reduce labor demands while maintaining product integrity.
This session challenges the idea that CGT facilities must remain so labor intensive. By examining how automation, robotics, and facility design can complement human expertise, this session explores practical ways to make CAR-T manufacturing more scalable and sustainable.
1400 – 1430
Pharma 4.0™ Compliant by Design
Sharon Adderley, PhD, Arcadis
The pharmaceutical industry is undergoing a significant shift driven by accelerated digitalization and the rapid growth of Advanced Therapy Medicinal Products (ATMPs). Regulatory frameworks are evolving in parallel, placing increased expectations on how digital tools, automation, and advanced manufacturing technologies are designed, validated, and governed across the product lifecycle. This session examines recent regulatory developments and emerging expectations that directly impact Pharma 4.0 implementation within ATMP manufacturing environments.
The presentation will focus on current EU and US regulatory guidance relevant to digital manufacturing, including data integrity, Computerized Systems Assurance (CSA), process analytical technology (PAT), real-time monitoring, and advanced control strategies. Particular attention will be given to how these expectations intersect with the unique challenges of ATMP manufacturing, including closed and automated processing, high variability, small-batch production, and stringent segregation and containment requirements.
The session will explore the implications of evolving regulatory expectations for digitalization, including data integrity, governance models, and validation approaches within ATMP manufacturing.
The presentation will focus on current EU and US regulatory guidance relevant to digital manufacturing, including data integrity, Computerized Systems Assurance (CSA), process analytical technology (PAT), real-time monitoring, and advanced control strategies. Particular attention will be given to how these expectations intersect with the unique challenges of ATMP manufacturing, including closed and automated processing, high variability, small-batch production, and stringent segregation and containment requirements.
The session will explore the implications of evolving regulatory expectations for digitalization, including data integrity, governance models, and validation approaches within ATMP manufacturing.
1430 – 1445
Networking
1445 – 1455
General Session
Laura Kuger, Takeda
Teresa Minero, LifeBee | a ProductLifeGroup Company
1455 – 1525
1525 – 1625
General Session
Laura-Ann Chin, PE, BW Design Group
Andrea Kurz, F. Hoffmann-La Roche Ltd in Basel
Hans Heesakkers, Circuition
Heath Coats, Dark Horse Consulting Group
Rick Friedman, FDA/CDER
Biopharma is entering a new era where advanced therapeutic modalities converge with digital transformation. Across mammalian and microbial systems, drug product manufacturing, peptides and synthetic biology, radiopharma, bioconjugates, cell and gene therapies, and even small molecules, the industry is facing increasing complexity alongside new opportunities for innovation and scale. At the center of this evolution is Pharma 4.0, enabling connected, data‑driven, and more flexible development and manufacturing. From AI and machine learning to digital twins and smart automation, digital technologies are reshaping the entire value chain—from discovery through production to supply. This panel discussion explores how Pharma 4.0 can: -Accelerate time to market -Improve process robustness and flexibility -Reduce cost of goods (COGs) across modalities -Enable scalable manufacturing for both established and emerging therapies This session will examine practical applications of digitalization across diverse manufacturing platforms, including continuous processing, process intensification, and modular or decentralized production models. Industry experts will address where these approaches deliver value—and where limitations remain—with real‑world insights into implementation, scalability, and regulatory considerations.
Laura-Ann Chin, PE
Director, Life Sciences
BW Design Group
BW Design Group
Andrea Kurz
Senior Director External Advocacy Europe and Middle East
F. Hoffmann-La Roche Ltd in Basel
F. Hoffmann-La Roche Ltd in Basel
Hans Heesakkers
Managing Director
Circuition
Circuition
Heath Coats
Senior Principal; Head of Quality & Compliance
Dark Horse Consulting Group
Dark Horse Consulting Group
Rick Friedman
Deputy Director, Office of Manufacturing Quality
FDA/CDER
FDA/CDER
1625 – 1630
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.